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Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. The Company also announced that it is commencing shipment through Global Pharmaceuticals, Impax’s generic division.

3 Mar 2010

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Lux Biosciences, Inc. today announced that the European Medicines Agency has accepted the filing of the company’s Marketing Authorization Application (MAA) for the company’s lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

3 Mar 2010

Combination of two targeted therapies effective against subset of gastric cancers: Study

A combination of two targeted therapies already shown to be effective in breast cancer packs an effective one-two punch against a subset of gastric cancers that have a specific genetic mutation, a study at UCLA's Jonsson Comprehensive Cancer Center has found.

3 Mar 2010

EMA validates Lux Biosciences' voclosporin MAA

Isotechnika Pharma Inc. today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) filed by its partner, Lux Biosciences, Inc., for voclosporin. Following validation of the MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review, which is expected to take one year.

2 Mar 2010

Generic Hyzaar and Cozaar litigation: Court of Appeals rules in favor of Teva Pharmaceutical Industries

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the District of Columbia Circuit has ruled in Teva’s favor by overturning a July 31, 2009, district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's antihypertensive agents Hyzaar® (hydrochlorothiazide; losartan potassium) and Cozaar® (losartan potassium).

2 Mar 2010

Generic version of Flomax Capsules receives FDA approval

The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

2 Mar 2010

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in 2010.

2 Mar 2010

FDA grants approval to Spectral Diagnostics for pivotal trial of Toraymyxin

Spectral Diagnostics Inc., a company developing products for the treatment of sepsis, today announced that the U.S. Food and Drug Administration has granted Investigational Device Exemption (IDE) approval for Toraymyxin, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, allowing the Company to conduct a pivotal trial in the United States.

2 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

FDA approves CombinatoRx's NDA for Exalgo extended-release tablets

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration has approved the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

2 Mar 2010

Sanquin Blood Supply Foundation, Netherlands Vaccine Institute launch AmpVacs project to develop influenza A vaccine

Sanquin Blood Supply Foundation, the Netherlands Cancer Institute, and the Netherlands Vaccine Institute announce today the launch of their joint AmpVacs project aiming at the development of a broadly protective synthetic influenza A vaccine component that in combination with classical antibody-stimulating vaccines will induce protection against future influenza A threats.

2 Mar 2010

Prenatal cocaine exposure affects sustained attention and self-regulated behavior in children

Children exposed to cocaine in the womb face serious consequences from the drug, but fortunately not in certain critical physical and cognitive areas as previously believed, according to a new comprehensive review of research on the subject from scientists at the University of Maryland School of Medicine. When a pregnant woman uses cocaine, it can interrupt the flow of nutrients and oxygen to the baby, putting such children at risk for premature birth, low birth weight and many other problems.

2 Mar 2010

AstraZeneca drafts five principles for companies engaged in social media

AstraZeneca today asked the U.S. Food and Drug Administration (FDA) to adopt guidance that will enable AstraZeneca and others to fully engage in real-time, social media conversations that responsibly provide accurate, balanced information on medicines from a known, identifiable and reliable source.

2 Mar 2010

First-ever international Omega-3 Awareness Day

Omega-3 Awareness Day, the nonprofit is proud to announce its plans for the first-ever international awareness day scheduled on March 3rd, 2010 at the University of California, Irvine. Teams of world-renowned doctors founded by Carol A. Locke, MD are scheduled to speak on the science and health benefits of Omega-3 essential fatty acids from 3:00 p.m. to 6:30 p.m. PST in front of thousands of students at UCI.

2 Mar 2010

Clot-busting drug therapy after stroke beneficial for women

New research shows women who don't receive a clot-busting drug after a stroke fare worse than men who are not treated. The study is published in the March 2, 2010, print issue of Neurology®, the medical journal of the American Academy of Neurology.

2 Mar 2010

Future work may uncover links between insulin use and cancer risk, say researchers

The benefits of using insulin to treat diabetes far outweigh the risks, but a review just published online by IJCP, the International Journal of Clinical Practice, suggests that commonly used diabetes therapies may differ from each other when it comes to their influence on cancer risk.

2 Mar 2010

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza.

2 Mar 2010

Most strains of pandemic H1N1 flu virus resist Tamiflu, say scientists

If the behavior of the seasonal form of the H1N1 influenza virus is any indication, scientists say that chances are good that most strains of the pandemic H1N1 flu virus will become resistant to Tamiflu, the main drug stockpiled for use against it.

2 Mar 2010

Scientists show omega-3 fatty acid and its derivatives kill neuroblastoma cancer cells

The next treatment for cancer might come from fish says a new research report published in the March 2010 print edition of the FASEB Journal (http://www.fasebj.org). In the report, scientists show that the omega-3 fatty acid, "docosahexaenoic acid" or "DHA," and its derivatives in the body kill neuroblastoma cancer cells.

2 Mar 2010

My Little Miracle Essay Contest: Winners to receive education fund prizes to support their children's future

If you are a parent who has conceived using Ferring Pharmaceuticals' fertility products, you can win a $10,000 education fund to support your child's future. Two other education fund prizes will also be awarded.

2 Mar 2010

Pharmaceutical News

Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Combination of two targeted therapies effective against subset of gastric cancers: Study

EMA validates Lux Biosciences' voclosporin MAA

Generic Hyzaar and Cozaar litigation: Court of Appeals rules in favor of Teva Pharmaceutical Industries

Generic version of Flomax Capsules receives FDA approval

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

FDA grants approval to Spectral Diagnostics for pivotal trial of Toraymyxin

InterMune seeks European marketing approval for pirfenidone

FDA approves CombinatoRx's NDA for Exalgo extended-release tablets

Sanquin Blood Supply Foundation, Netherlands Vaccine Institute launch AmpVacs project to develop influenza A vaccine

Prenatal cocaine exposure affects sustained attention and self-regulated behavior in children

AstraZeneca drafts five principles for companies engaged in social media

First-ever international Omega-3 Awareness Day

Clot-busting drug therapy after stroke beneficial for women

Future work may uncover links between insulin use and cancer risk, say researchers

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Most strains of pandemic H1N1 flu virus resist Tamiflu, say scientists

Scientists show omega-3 fatty acid and its derivatives kill neuroblastoma cancer cells

My Little Miracle Essay Contest: Winners to receive education fund prizes to support their children's future

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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